Aldeyra's Dry Eye Drug Faces Second FDA Rejection, but Hope Remains for Quick Resubmission

Aldeyra Therapeutics has encountered another setback in its pursuit of FDA approval for its dry eye disease treatment, reproxalap. The company's second application for the drug has been rejected, with the regulatory agency calling for additional study data. Despite this challenge, Aldeyra remains optimistic about a swift recovery, as it anticipates results from an ongoing trial that could pave the way for a rapid resubmission.

FDA Rejection and Requested Additional Data

The FDA's decision stems from concerns that Aldeyra's submission "failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eyes." Consequently, the agency has requested "at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye."

This rejection marks the second complete response letter (CRL) Aldeyra has received for reproxalap. The initial application in 2022 included data from two trials for ocular redness and two dry eye disease symptom field trials. However, the FDA deemed this insufficient and asked for at least one additional symptom trial.

Ongoing Trials and Resubmission Strategy

In response to the first CRL, Aldeyra initiated three trials specifically assessing dry eye disease symptoms:

1. A dry eye chamber trial
2. A trial in a different dry eye chamber
3. A six-week field trial

The company's second submission incorporated data from the first dry eye chamber trial, which successfully met its primary endpoint. However, the FDA expressed concerns "with the data from the trial submitted to the NDA that may have affected interpretation of the results," citing "methodological issues, including a difference in baseline scores across treatment arms."

Path Forward and Timeline

Despite this setback, Aldeyra has outlined a strategy for a swift return to the FDA:

1. The company expects to meet with the agency within 30 days to discuss the CRL.
2. Top-line results from the ongoing dry eye disease field trial are anticipated this quarter.
3. Depending on these discussions and data, Aldeyra aims to resubmit its application by mid-2025.
4. The company anticipates a six-month FDA review period following resubmission.

This aggressive timeline demonstrates Aldeyra's confidence in its ongoing trials and its commitment to bringing reproxalap to market as quickly as possible. The pharmaceutical industry will be watching closely as Aldeyra navigates this crucial period, potentially reshaping the landscape of dry eye disease treatment.